About This 510(k) Submission
K173593 is an FDA 510(k) clearance for the stay?safe catheter extension set with Safe-Lock, 12 inch, stay?safe catheter extension set with Luer-Lock, 6 inch, stay?safe catheter extension set with Luer-Lock, 12 inch, stay?safe catheter extension set with Luer-Lock, 18 inch, stay?safe to Luer-Lock adapter, 4 inch, a Set, Administration, For Peritoneal Dialysis, Disposable (Class II — Special Controls, product code KDJ), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on May 21, 2018, 181 days after receiving the submission on November 21, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.